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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Regulation of Medical Devices in Australia and New Zealand

Posted 01 February 2010 | By

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices in Australia according to criteria prescribed by the Therapeutic Goods Act of 1989 and related regulations.1,2 Since October 2002, the fundamental principles underlying medical device testing and assessment in Australia have been based on principles similar to those developed for the European Union that are part of a global harmonization approach through the Global Harmonization Task Force. However, the regulation of devices in Australia is unique in that an approval process resulting in the device's entry in the Australian Register of Therapeutic Goods (ARTG) must be followed.